ELLICOTT CITY, Md. — The Alliance of Sleep Apnea Partners, Inc., which advocates for sleep apnea patient safety and wellbeing, celebrates yesterday’s reintroduction of the Medical Device Recall Improvement Act, which could help patients during CPAP and other medical device recalls. The legislation “would require the Food and Drug Administration (FDA) to establish an electronic format for medical device recall notifications to streamline communication between device manufacturers, FDA, hospitals, and healthcare professionals,” according to a joint release from sponsors Senator Dick Durbin and Representative Jan Schakowsky, both of Illinois. 

 

ASAP fully supports the reintroduction of this legislation and applauds the efforts of Senator Durbin and Congresswoman Schakowsky to ensure that patients receive medical device recall information in a timely manner and can consult their doctors to make an informed decision regarding their care. 

ASAP also continues to encourage Congress and policymakers to increase safety, transparency, and accountability around medical devices, specifically respiratory therapy, by

• Establishing a centralized national registry for respiratory devices to efficiently track and alert patients and their doctors on recalled machines 

• Requiring automatic subrogation for insurance claims related to recalled devices so that insured patients can quickly get a replacement device without paying out-of-pocket to safely continue their CPAP therapy.

 

ASAP previously spotlighted the need for more effective recall communications in its 2024 report  “Philips Respironics Recall: Shaping Policy for Better Patient Outcomes,” which examined the recall’s negative impact on patient care and highlighted challenges it brought both for patients and their healthcare providers. The report recommended improvements to communication protocols among manufacturers, healthcare providers, patients, and regulatory agencies to ensure patients and their doctors receive more timely information and guidance. 

 

“Systemic gaps and lack of communication exacerbated many of the challenges that both patients and their healthcare providers faced during the Philips Respironics recall,” says Dr. Monica Mallampalli, President and CEO of ASAP. “That recall lasted four long years. We need to see improvements in the way FDA handles medical device recalls and stronger policies that ensure patients are better protected. We urge patients and caregivers to share their experiences with their federal legislators and to advocate for policies that put patient safety first.”

 

ASAP resources, including the Raise Your Voice advocacy toolkit and Fast Facts About Philips CPAP Recall empower sleep apnea patients and their caregivers to engage with their elected representatives.

For more information on our advocacy work related to the Philips Respironics recall, please visit apneapartners.org/philips-recall-information

 

About the Alliance for Sleep Apnea Partners

The Alliance for Sleep Apnea Partners (ASAP) is a U.S. based patient-oriented non-profit organization dedicated to improving the lives of people with sleep apnea through education, advocacy and support. Founded in 2018, ASAP is committed to promoting screening, diagnosis, treatment, and management of sleep apnea on behalf of the patient community to advance the lifelong well-being of sleep apnea patients.

 

Contact:
Monica P. Mallampalli, PhD

Alliance for Sleep Apnea Partners
info@apneapartners.org

855-545-1717